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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K192305
Device Name Colibri Endoscopy System
Applicant
3NT Medical Ltd.
22 HaMelacha St., POB 11384
Rosh Ha’Ayin,  IL 4809169
Applicant Contact Ehud Bendory
Correspondent
Orly Maor
25A Sirkin Street
Kfar Saba,  IL 4442156
Correspondent Contact Orly Maor
Regulation Number874.4760
Classification Product Code
EOB  
Date Received08/23/2019
Decision Date 02/27/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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